MAUDE Adverse Event Report: ABBOTT VASCULAR HT VERSATURN GUIDE WIRE

Model Number	1013319J
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a in-stent restenosis at birfurcation of the right coronary artery and posterior descending artery.Post dilatation was performed post stent implantation.During post dilatation, the versaturn guide wire became stuck/jailed between an old unspecified stent and the newly unspecified placed stent and the guide wire became unraveled.A guideliner was then advanced and assisted in getting all of the wires withdrawn from the anatomy altogether.Once removed it was noted that the guide wire core separated in two pieces but had been able to be all retrieved when it was withdrawn.Nothing remained in the anatomy.There was no adverse patient sequela and no clinically significant delay.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents/complaints from this lot.It was reported that during post dilatation, the versaturn guide wire became stuck/jailed between an old unspecified stent and the newly placed unspecified stent.It should be noted that the ht guide wires, pta, ptca, stents, instructions for use states: do not deploy a stent such that it will entrap the wire between the vessel wall and the stent.Although it was noted that the guide wire became inadvertently entrapped during post dilatation, this was due to the challenge of deploying a new stent in the proximity of a previously implanted stent.Therefore, the entrapped wire seems to be a reasonable clinical outcome.In this case, the physician reported the difficulties and is therefore aware of the issue.The investigation determined the reported difficulties and subsequent treatments appear to be related to the operational context of the procedure.Additionally, the reported removal of foreign body was due to a guide wire separation within the anatomy.There is no indication of a product quality issue with respect to manufacture, design, or labeling of the device.D9, h3: device status changed from returning to not returned.

• Brand Name: HT VERSATURN GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005737652; road no.2 km 58.0 cruce dávila; barceloneta PR 00617
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 15160545
• Report Number: 2024168-2022-08536
• Device Sequence Number: 12303846
• Product Code: DQX
• UDI-Device Identifier: 08717648198496
• UDI-Public: 08717648198496
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K141782
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 1013319J
• Device Catalogue Number: 1013319J
• Device Lot Number: 2041471
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2022
• Supplement Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 08/03/2022
• Supplement Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown